Australian public assessment report for Terlipressin



Yüklə 238,6 Kb.
səhifə1/6
tarix26.03.2018
ölçüsü238,6 Kb.
#33461
  1   2   3   4   5   6

therapeutic goods administration



August 2013

Australian Public Assessment Report for Terlipressin

Proprietary Product Name: Lucassin

Sponsor: Ikaria Australia Pty Ltd

About the Therapeutic Goods Administration (TGA)

  • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices.

  • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.

  • The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.

  • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.

  • To report a problem with a medicine or medical device, please see the information on the TGA website .

About AusPARs

  • An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.

  • AusPARs are prepared and published by the TGA.

  • An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications.

  • An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time.

  • A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA.

Copyright

© Commonwealth of Australia 2013


This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to .

Contents



List of abbreviations 4

I. Introduction to product submission 5

Submission details 5

Product background 5

Regulatory status 6

Product Information 7

II. Quality findings 7

Drug product 8

Biopharmaceutics 8

Quality summary and conclusions 8



III. Nonclinical findings 8

Introduction 8

Pharmacology 9

Pharmacokinetics 11

Toxicology 12

Nonclinical summary and conclusions 17



IV. Clinical findings 19

Introduction 19

Pharmacokinetics 20

Pharmacodynamics 20

Efficacy 21

Safety 27

List of questions 28

Clinical summary and conclusions 28



V. Pharmacovigilance findings 30

VI. Overall conclusion and risk/benefit assessment 31

Quality 31

Nonclinical 31

Clinical 32

Risk management plan 37

Risk benefit analysis 38



Outcome 42

Attachment 1. Product Information 43

Attachment 2. Extract from the Clinical Evaluation Report 43


List of abbreviations


Abbreviation

Meaning

AVP

Arginine vasopressin (endogenous vasopressin or ADH)

EVH

(E) oesophageal Variceal Haemorrhage

FHVP

free hepatic venous pressure

HR

Heart rate

HVPG

Hepatic venous pressure gradient

IEVP

intravascular oesophageal variceal pressure

IHC

intrinsic hepatic clearance

IVP

Intravariceal pressure

HRS

Hepatorenal Syndrome

LVP

Lycine-Vasopressin

MAP

Mean arterial pressure

MELD Score

The Model for End stage Liver Disease (MELD) score is a disease severity scoring system used to rank adult patients waiting for liver transplantation. It is a composite of total bilirubin, INR and SCr. The MELD score numerically ranks patients from 6 (less ill) to 40 (gravely ill).

MPBFV

mean portal blood flow velocity

PBFV

Portal blood flow velocity

PVF or PVBF

Portal venous blood flow

SCr or SeCr

Serum Creatinine

TdP

Torsades de pointes

TGLVP

Triglycylvasopressin (terlipressin)

VPG

Variceal pressure gradient

VWT

Estimated variceal wall tension

WHVP

Wedged hepatic venous pressure

WMD

Weighted Mean Differences



Yüklə 238,6 Kb.

Dostları ilə paylaş:
  1   2   3   4   5   6




Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©genderi.org 2024
rəhbərliyinə müraciət

    Ana səhifə